The Food and Drug Administration (FDA) first announced a shortage of amphetamine mixed salts, the primary ingredient in the prescription stimulant Adderall, in October 2022. While the agency originally estimated the shortage would last until March 2023, it persists to this day.
Now, a new survey shows how many patients have been forced to go without their medication.
According to a report out this week from health research firm Truveta, "there was a decrease in the rate of amphetamine/dextroamphetamine (Adderall) prescription fills per eligible population starting in the fall of 2022."
Truveta arrived at this conclusion by comparing the anonymized health records of 336,355 people "who had an ADHD diagnosis and amphetamine/dextroamphetamine prescription fill between January 2016 and December 2023."
The firm found that "prescription fill rates were 11.4% lower in the first five months of 2023 compared to the first five months of 2022." The rate was higher among adults, who experienced a 12.4-percent drop compared to a 10.3-percent decrease among those under 18.
While the shortage has been a fact of life for a year and a half, the Truveta survey provides insight into the extent of its impact.
Adderall is most often used to treat attention-deficit/hyperactivity disorder (ADHD), though it is also an approved treatment for narcolepsy. Without a reliable supply of medication, patients with ADHD can experience problems with inattention and an inability to sit still, potentially causing problems at school or work. Narcoleptics, meanwhile, struggle to stay awake during the day, even while driving.
As Reason has reported since the FDA's first announcement, the federal Drug Enforcement Administration (DEA) imposes annual aggregate production quotas (APQs) on Schedule I and Schedule II narcotics. The DEA limits how much of each particular substance can be developed per year, and companies request a piece of that total.
After an increase in ADHD diagnoses early in the COVID-19 pandemic, prescriptions for stimulants skyrocketed. But the DEA has so far not raised the limits on the chemicals used to manufacture those drugs: As recently as January, the DEA noted that while it was "aware of patient reports that pharmacies are unable to fill prescriptions for their prescribed Adderall or one of its generic versions," the agency "has not implemented an increase to the APQ for amphetamine at this time."
The government's explanation is that drug manufacturers are already not producing enough. "For amphetamine medications, in 2022, manufacturers did not produce the full amount that these limits permitted them to make," according to an August 2023 letter from DEA Administrator Anne Milgram and FDA Commissioner Robert Califf.
But in 2022, the three largest pharmaceutical distributors (along with Johnson & Johnson) settled a $26 billion lawsuit brought by state and local governments over perceived complicity in the opioid epidemic. As a result, distributors have cracked down on orders of potential high-risk drugs, including Adderall.
In February, New York magazine reported on Ascent Pharmaceuticals, a Long Island-based drug manufacturer that once made as much as 20 percent of the U.S.'s entire ADHD medication supply but has been shut down for two years over apparent discrepancies with its record keeping.
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